- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell
subtype with primary tumor resected
- At least one measureable lesion as defined by Response Evaluation Criteria In Solid
Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group performance status 0 or 1
- Controlled hypertension
- Prior treatment with systemic therapy for advanced RCC
- Prior adjuvant or neoadjuvant therapy if disease progression or relapse has occurred
during or within 12 months after the last dose of treatment
- Prior treatment with any agent specifically targeting T-cell co-stimulation or
checkpoint pathways
- Active seizure disorder or evidence of brain metastases, spinal cord compression, or
carcinomatous meningitis
- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of
randomization except for adequately treated basal cell or squamous cell skin cancer,
or carcinoma in situ of the breast or of the cervix or low grade prostate cancer with
no plans for treatment intervention
- In past 12 months: myocardial infarction, uncontrolled angina, coronary/peripheral
artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident,
or transient ischemic attack
- In past 6 months: deep vein thrombosis or pulmonary embolism